NCT05693740

Accelerated Corneal Collagen Crosslinking Protocols

Pulsed Light Versus Continuous Light Accelerated Epithelium-Off Cross-linking for Treatment of Progressive Keratoconus; a Prospective Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare the effect of pulsed light (pl-ACXL) accelerated and continuous light accelerated (cl-ACXL) epithelium-off cross-linking in halting the progression of keratoconus.

Detailed description

Keratoconus (KC), which was first described in detail in 1854, is the most common corneal primary ectasia and is characterized by progressive bilateral and asymmetric corneal thinning and bulging outward into a cone-like shape that can severely impact patients' vision. Keratoconus usually develops in the second and third decades of life and progresses until the fourth decade. It was thought to be a rare corneal disease. Despite a great deal of research, no one theory explains it all and it may be caused by a combination of things. However, Meek proposed that the loss of structural integrity in the KC cornea was caused by the presence of abnormal keratocytes and matrix proteins and upregulated proteolysis triggered an unravelling of lamellae along their length and from their anchors at the limbus, with an opening of the lamellar bifurcations. This theory is supported by observations following riboflavin/UVA collagen cross-linking, where the proposed cross-linkage of the tissue increases both the resistance of the stroma to enzymatic digestion and the cohesiveness between collagen fibrils and the non-collagenous matrix. Conventional CXL (CXL) with a continuous irradiation of 3 mW/cm2 for 30 min is considered safe and effective in the prevention of keratoconus progression according to different clinical trials. nevertheless, the procedure is time-consuming, lasting around 1 h, which may lead to patient discomfort and reduced physician working efficiency. With evolving technical advances, commercially available UV light sources have been developed, making CXL more efficient with shorter UV exposure times, higher UV intensities, and pulsed light compared with continuous light settings. Various accelerated CXL protocols have been described and its effect on biomechanical properties on corneas stated as equal to the standard protocol. Ex-vivo studies also suggest a distinction between various accelerated CXL protocols by providing evidence for a drop in efficiency with increased UV illumination intensity while maintaining equal surface energy. In this study we evaluate the two types of "accelerated crosslinking".

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	Accelerated crosslinking (ACXL)	Epithelium-off accelerated corneal crosslinking is a procedure in which the cornea is soaked with riboflavin followed by exposure to ultraviolet irradiation in either pulsed-light or continuous-light modes to strengthen the corneal stroma and halt keratoconus progression.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-01-23
• Last updated: 2025-01-29

Locations

1 site across 1 country: Egypt